Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status and phase: Completed; Phase 2

Conditions: Non Muscle Invasive Bladder Cancer

Treatments: Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT02343614

2401 (Other Identifier)

Details and patient eligibility

About

The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models.

Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven urothelial bladder cancer
• Intermediate risk NMIBC
• ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
• Imaging study excluding upper urinary tract TCC

Exclusion criteria

• Pregnant and lactating women;
• Advanced co-existing medical or psychiatric disorders;
• Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
• History of allergy to sulfonamide drugs;
• Concomitant investigational medications.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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58 participants in 1 patient group

ARM A

Experimental group

Description:

Patients undergoing treatment with oral celecoxib

Treatment:

Drug: Celecoxib